The Efficacy and Safety of Caffeic Acid for Esophageal Cancer (CAEC)
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|ClinicalTrials.gov Identifier: NCT03070262|
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : April 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Esophagus Cancer||Drug: CA Drug: placebo group||Phase 3|
Background: More than half of global esophageal cancer cases came from China.80 percentage patients were diagnosed with advanced disease and suffered from the poor outcome.With the development of target therapy among cancers,the overall survival and life quality of patients has been continuous improved recently.However,there had little reports focusing on target therapy in esophageal cancer . Caffeic acid as an ordinary drug is used for thrombocytopenia when patient received chemotherapy. Newly studies shown caffeic acid can target inhibit GASC1 expression, and GASC1 is confirmed to be a new oncogene in esophageal cancer.
Aim: to investigate the efficiency and safety of caffeic acid in chinese advanced esophageal squamous cell cancer.
Methods: 240 advanced ESCC patients will be randomized to two arms: CA group (receiving coffeic acid treatment) or placebo group. In CA group, patients will receive coffeic acid treatment: 100-200mg, tid, po, 2 weeks treated then 1 week black interval(weight >50kg, 200mg per time, weight < or =50kg, 100mg per time); in placebo group, the same shape placebo tablets will be deliveried to patients. 1 years follow-up for both groups patients.Patients in both arms can receive any other ways of anti cancer therapy in the same time.
Primary endpoints: 3 months PFS; Second endpoints: 1 year OS
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Caffeic Acid for Advanced Esophageal Squamous Cell Cancer: A Randomized, Double-blind, and Multicenter Trial in Chinese Patients|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: CA group
caffeic acid (300mg, tid, po) continue given until progression of disease or death, or patients are unable to bear the side effects
caffeic acid, 300mg, tid, po
Placebo Comparator: placebo group
the same shape placebo tablets continue given until progression of disease or death, or patients are unable to bear the side effects
Drug: placebo group
placebo tablet, 3 tablets, tid, po
- 3 months PFS % [ Time Frame: 3 months ]The percentage of 3 months progression-free survival (PFS) after random allocation. PFS was defined as the time from randomisation to disease progression or death as assessed by the treating physicians in the study through CT scan, gastroscopy and biopsy pathology, X-ray barium meal.
- 1 year OS % [ Time Frame: 1 year ]The percentage of 1 year overall survival (OS) after random allocation. The follow-up will be done every 3 months through phone call, investigator visiting, and medical recording review.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070262
|The Clinical Medical College, The First Affiliated Hospital of Henan University of Science and Technology|
|Luoyang, Henan, China, 471003|
|Study Chair:||Shegan Gao, PhD||The Clinical Medical College, The First Affiliated Hospital of Henan Science and Technology|